Abstract: On March 11, 2003, the European Union (EU) published the 7th Amendment to its Cosmetic Directive 76/768/EEC. Among the changes was the addition of the 26 popular fragrance ingredients to the Annex III “List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down.” These are now commonly referred to as the EU Fragrance Allergens.

Market Data

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Regulatory

Market Intelligence

The European Union (EU) began reviewing the safety of fragrance ingredients used in cosmetics in the late 1990s. This came from non-governmental organizations (NGOs) pressuring for the 100% safety of all ingredients. This mandate was given to the EU Commission and in turn was assigned to the scientific advisory committee. The committee’s response was to recommend that the EU prohibit some ingredients and restrict others. It came out with a list of 26 ingredients mostly found in fragrances and essential oils that, if present at certain levels or higher, must be listed as part of the product’s ingredient listing. The listing of these 26 allergens was intended to alert customers of their presence so they can avoid using the product if they are allergic to those chemicals. This has only made ingredient listings more complex; in fact, some marketers have tried to avoid using these ingredients or essential oils in their fragrances. However, few have been successful since these 26 ingredients include the most popular fragrance components.

On March 11, 2003, the EU published the 7th Amendment to its Cosmetic Directive 76/768/EEC. Among the changes was the addition of the 26 popular fragrance ingredients to the Annex III “List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down.” These are now commonly referred to as the EU Fragrance Allergens.

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The European Union (EU) began reviewing the safety of fragrance ingredients used in cosmetics in the late 1990s. This came from non-governmental organizations (NGOs) pressuring for the 100% safety of all ingredients. This mandate was given to the EU Commission and in turn was assigned to the scientific advisory committee. The committee’s response was to recommend that the EU prohibit some ingredients and restrict others. It came out with a list of 26 ingredients mostly found in fragrances and essential oils that, if present at certain levels or higher, must be listed as part of the product’s ingredient listing. The listing of these 26 allergens was intended to alert customers of their presence so they can avoid using the product if they are allergic to those chemicals. This has only made ingredient listings more complex; in fact, some marketers have tried to avoid using these ingredients or essential oils in their fragrances. However, few have been successful since these 26 ingredients include the most popular fragrance components.

On March 11, 2003, the EU published the 7th Amendment to its Cosmetic Directive 76/768/EEC. Among the changes was the addition of the 26 popular fragrance ingredients to the Annex III “List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down.” These are now commonly referred to as the EU Fragrance Allergens.

The origins of this regulation go back to the Scientific Committee on Cosmetic and Non-Food Products (SCCNFP) opinion adopted on June 23, 1999, that was issued in response to the EU’s following questions:

Does the SCCNFP agree to the inclusion of all International Fragrance Association (IFRA) restricted materials into the Annex III “List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down?” Are the permitted usage levels recommended by IFRA suitable for use in the Cosmetics Directive 76/768/EEC?

Does the SCCNFP agree that all materials that IFRA recommend not to be used as fragrance compounds be included in the Annex II “List of Substances Which Must Not Form Part of the Composition of Cosmetic Products?”

It is proposed that all known fragrance allergens are labeled on cosmetics if used in the product. Does the SCCNFP agree to this proposal? If so, which chemicals fall under this classification? Is there a maximum ­concentration of each chemical permissible without the requirement for labeling?

Restrictions are proposed for the three most common fragrance allergens, i.e., cinnamic aldehyde, isoeugenol and hydroxycitronellal. Does the SCCNFP agree to restrictions on the use of common fragrance allergens, i.e., listing them in Annex III?

If so, which fragrance materials should be subject to restrictions? Also, what are the conditions for restrictions, e.g., maximum concentration, fields of application, etc.?

On Dec. 8, 1999, the SCCNFP issued its replies to these questions. The response was divided into two sections. First was the identification of fragrance ingredients of potential concern as allergens for the consumer. Recommendations were given to inform the consumer of the presence of these allergens to provide those with known fragrance allergies a means to avoid contact with the given allergen. An opinion was given as to whether such identification could be related to concentrations present in a product when elicitation levels are known. Second, the group gave its opinion on the adoption of industry-prohibited substances into Annex II and industry-restricted substances into Annex III.

Considerations as to whether the concentration limits or other restrictions suggested by industry could be supported were given, as well as required changes for such inclusion in Annex III. Also, any additional substances that should be subject to inclusion in an Annex were noted.

The group reported, “It is the opinion of the SCCNFP that fragrance ingredients have to be considered an important cause of contact allergy. [Also,] based on criteria restricted to dermatological data reflecting the clinical experience, it has been possible to identify 24 fragrance ingredients, which correspond to the most frequently recognized allergens.” Of the 24, only 13 have been reported more frequently and are well-recognized contact allergens by consumers (see Table 1), and thus are of the most concern; the 11 others are less well-documented.

Not included in the list of known allergens were natural ingredients like oak moss, as they are considered “complex mixtures.” The SCCNFP acknowledged that of the 24 allergens, only 7 are included in the fragrance mix for allergy testing,a including: amyl cinnamal, cinnamyl alcohol, cinnamal, eugenol, geraniol, hydroxycitronellal, isoeugenol and oak moss.

On Sept. 25, 2001, the SCCNFP issued its opinion that 28 fragrance ingredients should be restricted and added to Annex III of the EU Cosmetic Directive. These 28 ingredients included 14 entries under the Pinacea family, 11 esters of allyl alcohol, 11 ingredients that could contain furocoumarin-like substances, 3 types of Peru balsam, 7 Damascone types, and 5 oak moss/tree moss products. The total they proposed restricting was 79 fragrance ingredients. Further, on June 23 and 24, 2003, the SCCNFP published an opinion that the source of the allergen did not matter; that allergens found in essential oils are no different than those made synthetically and/or are deliberately added to a fragrance.

With the publication of the 7th Amendment, the 26 allergens finally determined are now required to be listed if their total amount present in a cosmetic is above 0.01% for rinse-off products and 0.001% for leave-on products. Some of the other fragrance ingredients were listed in Annex III with restrictions on levels but they are not required to be listed out like these 26, which cause the most allergic reactions. These 26 allergens are listed in Table 2 with their frequency of use as reported to the US Food and Drug Administration (FDA). The number for benzyl alcohol reflects all registrations, whether used as a preservative or an EU allergen. Those marked with an asterisk (*) are listed on the EU’s Dangerous Substance Directive (DSD). The sellers of cosmetics that contain any ingredient on the DSD are required to disclose the quantitative amount in the cosmetic, if requested by a consumer.

As the SCCNFP stated that the origin of the allergen was not relevant, Table 3 lists the 25 most common ­essential oils according to the FDA’s voluntary registration program, along with their approximate percentage of total allergens and the allergen with the highest level. The levels of allergens could vary from lot to lot.

Since the passage of the labeling requirement, the former SCCNFP, now referred to as the Scientific Committee on Consumer Safety (SCCS), has issued other opinions on two of these 26 allergens due to additional consumer complaints of allergic reactions. The first was to recommend the restriction of hydroxyisohexyl 3-cyclohexene carboxaldehyde to a maximum level of 0.02% in a cosmetic; while the second opinion was to limit the level of atranol and chloroatronal allowed in oakmoss extract (INCI: Evernia Prunastri (Oakmoss) Extract) to < 2 ppm. This would generally translate to 0.01% of the extract allowed in a cosmetic. Neither of these opinions has been adopted to the EU Cosmetic Regulations as of this writing.

Comments

It is clear that there is significant compliance with the labeling of cosmetics that contain the EU Fragrance Allergens. Other countries will be adopting this and this author suspects it will also be the case in the United States at some time in the future. Since the test kita only contained 8 of the 26 allergens, a second kit called EU Fragrance Mix II was introduced. It contains 6 more allergens totaling 14%, in petrolatum: citronellol 0.5%, ­citral 1%, coumarin 2.5%, hydroxyisohexyl 3-cyclohexene carboxaldehyde 2.5%, farnesol 2.5% and alpha-hexyl-cinnamal 5%. Of these, hydroxyisohexyl 3-cyclohexene carboxaldehyde seems to cause a significant number of allergic reactions. This ingredient is frequently found in women’s fragrances and deodorants.

In December 2011, the SCCS issued a detailed opinion on fragrance allergens in cosmetics, suggesting there are 50+ others that should also appear on the ingredient list, similar to the original 26 (see Table 4).

Most of the natural extracts proposed contain some of the 26 allergens already listed. Imagine an ingredient label if the first 26 were expanded to include all of these additional allergens. However, the really important question is: Has this new labeling changed anything? Since the test kit is limited, individuals who have reactions are diagnosed with limited allergens. They may not be tested with the culprit and as a result, may avoid all fragrances. This is even a bigger issue as products proclaiming “fragrance free” might have these allergens present as essential oils or in other ingredients. And since these 26 ingredients are the most popular components of fragrances, there has been little movement to avoid using them in fragrances.

Perhaps the only real positive result of all this additional labeling is to avoid the term hypoallergenic when these 26 allergens are labeled as being present. As the FDA says on its website, “There are no Federal standards or definitions that govern the use of the term ‘hypoallergenic.’ The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypo- allergenicity claims to FDA. The term ‘hypoallergenic’ may have considerable market value in promoting cosmetic products to consumers on a retail basis but dermatologists say it has very little meaning.”

This author thinks it would be difficult to defend a “hypoallergenic” claim if the product listed fragrance allergens. It is also interesting to note that most consumers still do not read ingredient listings and often are persuaded that the product contains “good” or “bad” ingredients based on negative advertising or junk science. It all boils down to caveat emptor.

This content is adapted from an article in GCI Magazine. The original version can be found here.

Table 1. Most frequently recognized contact allergens

Table 2. The 26 allergens required to be listed if present in a cosmetic

Table 2. The 26 allergens required to be listed if present in a cosmetic

Table 3. The 25 most commonly used essential oils according to the FDA’s voluntary registration program

Table 3. The 25 most commonly used essential oils according to the FDA’s voluntary registration program

Table 4. SCCS suggestions for additional allergens that should appear on the ingredient list

Table 4. SCCS suggestions for additional allergens that should appear on the ingredient list

Biography: David C. Steinberg, Steinberg & Associates

David C. Steinberg founded Steinberg & Associates, a consulting firm based in Plainsboro, NJ, USA, in 1995. Co-founder of the graduate program in cosmetic sciences at Fairleigh Dickinson University, where he lectured for 18 years on cosmetic chemistry, Steinberg has more than 35 years of experience in marketing, technical service and regulatory affairs in the personal care industry. In addition, he was president of the Society of Cosmetic Chemists in 1991. Steinberg is a frequent speaker worldwide on cosmetic regulations and preservation as well as sunscreen and cosmetic ingredient chemistry. In 2009, he was honored as the first regulatory expert in personal care to be granted fellow status by the Regulatory Affairs Professional Society. He wrote the Alluredbook, Preservatives for Cosmetics, Third Edition.